Fecal incontinence (FI), or the inability to control bowel movements, is an immense unmet clinical need, especially among women, who are 9 times more likely to suffer from the disease than men. While stigma surrounding the disease has masked the prevalence of the condition for decades, recent community-based studies estimate that up to 17 million women suffer from FI in the U.S. alone. The disease is psychologically and emotionally devastating, causing those afflicted to avoid going out in public and greatly reducing their quality of life. With no good treatments, most patients are left to cope with the disease wearing diapers.
Prevalence rates are higher in women because of the trauma caused to the pelvic floor during pregnancy and child delivery. Contributing pathophysiologies include damage to the external or internal anal sphincters, the pudendal nerve, the levator ani, and other muscles in the pelvic floor. This damage can immediately result in symptoms, or symptoms can not manifest until later in life. The latter is due to the fact that as this population ages, they experience age-related decreases in general continence mechanisms, such as changes in rectal sensation, compliance, and volume, in addition to further weakening of the sphincters and pelvic floor muscles. The average age of onset of symptoms is surprisingly young—51 years of age.
Many women with FI have multiple defects in their continence mechanisms, making it a very difficult condition to treat. This is one of the reasons why many treatments have previously failed, as they only work to address a single cause (e.g. sphincter tears or nerve damage). Conservative attempts to control fecal incontinence, including dietary changes and physical therapy have been largely unsuccessful.
More invasive approaches have been tried to statically reduce the size or change the angle of the anorectal canal. Such approaches include: injectable bulking agents—a substance that gets injected into the walls of the canal; sphincteroplasties—a surgical method of tightening the sphincter; and rings and slings—devices placed partially or all the way around the rectum. Such treatments have shown poor results, likely because they are fundamentally static devices and cannot achieve a dynamic and controllable function like a healthy sphincter. Devices such as American Medical System's Acticon Neosphincter address this problem by functioning as an artificial sphincter that the patient can control. The neosphincter consists of a cuff placed around the rectum, a patient-controlled pump implanted in the labia, and a reservoir implanted in the abdomen. Such devices have better dynamic range, but their invasive nature has led to infection, erosion, and removal rates. As a result, very few such procedures are performed. Therefore, a great need exists for a dynamic treatment to fecal incontinence that is not invasive.
U.S. Patent Application Publication No. 20060211911 to Jao, et al. discloses a vaginal insert having a cylindrical front projection 11 and a head 20 at the rear end thereof for holding by a person's hand. In use, and as shown in FIG. 6, the person holds the head 20 and then inserts the cylindrical front projection 11 into the vagina 30 to push the rectovaginal septum 50 outward against the rectum 40, thereby guiding accumulated excrement 70 back to the rectum 40. The Jao, et al. device generally aids in the passage of stool, not prevention of stool passage. It demonstrates that rectal contents can be controlled intra-vaginally. However, it discusses nothing that would occlude the rectum to prevent stool. It also does not discuss something that would stay in the vagina in order to control stool passage. Further, it discusses nothing that could fit stably in the vagina in order to control the rectum.
U.S. Pat. No. 6,013,023 to Klingenstein discloses a device for controlling fecal incontinence of a hollow, tubular member 1 defining a longitudinal cavity 2 that terminates in a closed proximal end 3 and an expandable sheath 6. Wings 13 can also assist in holding the device in place.
A major drawback of Klingenstein's device is the means provided for stabilizing the device, which is essential to carry out the desired functionality. Klingenstein describes wings external to the vagina, which would be uncomfortable and cumbersome for patients. He also describes device expansion as a means for securing the device. It was discovered in Applicants' cadaver studies, that an intra-vaginal device where securing relies on expansion is inherently unstable when the device is unexpanded. It was further discovered that when such devices transition from unexpanded to expanded states, their positioning and directionality is variable and unpredictable. This is especially problematic when the goal is to use the vaginal device to apply a directed force to the rectum. For one, if the device is inserted in an unexpanded state, it makes it difficult to reliably expand to apply a force on the right spot. Additionally, throughout the course of use, patients can wish to deflate, but not remove, the device for defecation or other activities when they feel active bowel control is not needed. In these cases, as is the case initially, the instability upon deflation would make it difficult to re-expand in the right position. An improvement to Klingenstein's device would be one that has a stabilization means that is intra-vaginal and does not rely on expansion of the device. This would allow comfortable, repeatable application of force to the same portion of a patient's posterior vagina.
Another drawback to the stability of Klingenstein's device is that it is a tubular device, more specifically defined as generally cylindrical. Applicants' reduction to practice has revealed that this type of shape does not stably rest in the vagina, especially if force is applied towards the recto-vaginal septum, as it tends to rotate. An improvement to the art is a device designed to prevent rotation around the axis formed by the distal and proximal ends of the device, such that it can remain in the appropriate position to exert a repeatable force on the proper part of the recto-vaginal septum.
Another major drawback of Klingenstein's device is that it lacks body means to allow easy force transfer from the vagina to the rectum. Applicants' experimentation has revealed the importance of the availability of redundant vaginal tissue to maintain force on the rectum. If a device is not designed to allow redundancy (or slack) in the vaginal wall in the area where the force is transmitted to the rectum, then the tension in the wall makes it difficult to transfer the force posteriorly. Klingenstein does not teach any art that would allow for such vaginal slack in the area where his device transmits force to the rectum. An improvement to the art would therefore describe a device that has a design to allow for sufficient slack to remain in the vaginal walls adjacent the force apply portion such that force is easily transmitted to the rectum.
There are a variety of pessaries in the prior art. These devices are usually indicated for the treatment of pelvic organ prolapse, in which they support organs, such as the uterus, from prolapsing into the vaginal canal. There are also other intra-vaginal devices in prior art for the purposes of birth control, urinary incontinence, and other conditions. These devices come in different shapes. Some have the ability to expand, but not in a directionally applied manner. None of these intra-vaginal devices are designed to be able to apply a directed force towards the rectum, let alone the ability to do so stably, repeatedly and with minimal force.
Therefore, there remains a need for a fecal incontinence device that can be inserted in the vagina and stably apply a force to the rectum in order to control the passage of stool. Such a device has not previously been conceived, and as a result there are no such devices in the market place and, more generally, no viable treatment for the millions of women suffering from fecal incontinence. Described below is a device for treating fecal incontinence, which explores the unique combination of stability and directed rectal occlusion.